托珠单抗联合甲氨蝶呤治疗难治性类风湿关节炎的疗效观察
Observation of the efficacy of tocilizumab in combination with methotrexate for the treatment of refractory rheumatoid arthritis

目的 ·探讨托珠单抗联合甲氨蝶呤治疗难治性中重度活动的类风湿关节炎（RA）的有效性及安全性。 方法 · 10例难治性活动性RA患者接受足量托珠单抗注射液联合甲氨蝶呤口服治疗，观察治疗前（基线）及治疗第12、24周时压痛关节数、肿胀关节数、红细胞沉降率（ESR）、C反应蛋白（CRP）及疾病活动指数28(DAS28)、简化疾病活动指数（SDAI）和临床疾病活动指数（CDAI）等指标的变化，记录不良反应发生情况。 结果 ·与治疗前比较，治疗后第12周和第24周RA患者的关节症状、体征、ESR及DAS28、CDAI、SDAI等指标均有不同程度改善，差异均有统计学意义（P<0.05）。无白细胞减少、心功能不全及严重感染等不良反应发生。 结论 ·托珠单抗能快速并显著地改善难治性活动性RA患者的临床症状、体征、活动性指标及关节炎评分。
： Objective · To investigate the efficacy and safety of tocilizumab in combination with methotrexate (MTX) for the treatment of refractory rheumatoid arthritis (RA) with moderate to severe activity. Methods · Ten patients with refractory active RA underwent tocilizumab injection in combination with oral MTX. Changes in indexes such as tender joint count (TJC), swollen joint count (SJC), blood sedimentation (ESR), C reactive protein (CRP), disease activity score 28 (DAS28), simplified disease activity index (SDAI), and clinical disease activity index (CDAI) were observed before (baseline), 12 weeks, and 24 weeks after treatment and adverse reactions were documented. Results · After treatment for 12 and 24 weeks indexes including joint symptoms, signs, ESR, DAS 28, CDAI, and SDAI significantly improved than baseline(P<0.05). No adverse reactions such as leukopenia, cardiac insufficiency, and severe infection were observed. Conclusion · Tocilizumab can rapidly and significantly improve clinical symptoms, signs, active indexes, and arthritis scores for patients with refractory active RA